A diagram on the sequence and interactions of a Quality Management System, based on ISO13485:216.

1. Design Control
(Planning, Inputs,
Outputs, Review,
V&V)
Material Control
including
Customer
Property
(Purchasing)
Production and
Process Control
including Process
Validation
Product Control
(Monitoring and
Measuring of
Product)
Distribution
Control
Customer
Feedback
including
Complaint
Handling Process
Reporting to
Regulatory
Authorities
Design Transfer
Design Change
Control
Control of Monitoring and Measuring Equipment
Preservation of Product
Work environment and contamination control
Infrastructure (including maintenance)
Medical Device File
Design and Development Files
Planning of Product Realization, including Risk Management
Control of Nonconforming Product
Internal Audit; Monitoring and Measurement of Processes; Analysis of Data; Improvement (CAPA)
Management Commitment; Customer Focus; Quality Policy; Quality Objectives; QMS Planning (including Change Control);
Responsibility, Authority and Communication; Management Review
ProvisionofResources;HumanResources(Training)
QMSDocumentation;QualityManual;
ControlofDocuments;ControlofRecords
Sequence and Interaction of QMS Processes
4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, Analysis and Improvement
QMS Clause
Customer Related Processes
Servicing
Activities
Identification and Traceability